Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE...

60
1 ANNEX I

Transcript of Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE...

Page 1: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

1

ANNEX I

Page 2: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

2

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Austria Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Austria Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Austria Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Austria Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Austria Riemser Pharma Gmbh

Vancomycin Enterocaps 250 Mg Kapseln

VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE

CAPSULE, HARD ORAL USE

Austria Hikma Farmacêutica (Portugal), S.A.

Vancomycin Hikma VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Austria Hikma Farmacêutica (Portugal), S.A.

Vancomycin Hikma VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Austria Hikma Farmacêutica (Portugal), S.A.

Vancomycin Hikma VANCOMYCIN 50MG/ML

POWDER FOR CONCENTRATE FOR

INTRAVENOUS USE

Page 3: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

3

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

SOLUTION FOR INFUSION

Austria Mip Pharma Austria Gmbh

Vancomycin Mip VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Austria Mip Pharma Austria Gmbh

Vancomycin Mip VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Austria Arcana Arzneimittel Gmbh

Vancomycin Mylan VANCOMYCIN 50MG/ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Austria Noridem Enterprises Ltd

Vancomycin Noridem VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Austria Noridem Enterprises Ltd

Vancomycin Noridem VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Austria Pfizer Corporation Austria Gesellschaft M.B.H.

Vancomycin Pfizer VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Austria Pfizer Corporation Austria Gesellschaft M.B.H.

Vancomycin Pfizer VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Austria Xellia Vancomycin Xellia VANCOMYCIN POWDER FOR INTRAVENOUS USE

Page 4: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

4

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Pharmaceuticals Aps HYDROCHLORIDE 513MG VIAL

SOLUTION FOR INFUSION

Austria Xellia Pharmaceuticals Aps

Vancomycin Xellia VANCOMYCIN HYDROCHLORIDE 1026MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Austria Hospira Deutschland Gmbh

Vanycin VANCOMYCIN 50MG/ML

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Belgium Teva Pharma Belgium N.V.-S.A

Vamysin VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Belgium Teva Pharma Belgium N.V.-S.A

Vamysin VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Belgium Cnp Pharma Gmbh Vancomycin Cnp Pharma

VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Belgium Cnp Pharma Gmbh Vancomycin Cnp Pharma

VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Belgium Hospira Benelux Bvba

Vancomycin Hospira VANCOMYCIN 50MG/ML

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Belgium Hospira Benelux Vancomycin Hospira VANCOMYCIN POWDER FOR INTRAVENOUS USE,

Page 5: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

5

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Bvba HYDROCHLORIDE 50MG/ML

SOLUTION FOR INFUSION

ORAL USE

Belgium Hospira Benelux Bvba

Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 50MG/ML

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Belgium Mylan Bvba-Sprl Vancomycin Mylan VANCOMYCIN 50MG/ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Belgium Mylan Bvba-Sprl Vancomycin Mylan VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Belgium Mylan Bvba-Sprl Vancomycin Mylan VANCOMYCIN 500MG/ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Belgium Fresenius Kabi Nv-Sa Vancomycine Fresenius Kabi

VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Belgium Fresenius Kabi Nv-Sa Vancomycine Fresenius Kabi

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Belgium Mylan Bvba-Sprl Vancomycine Mylan VANCOMYCIN 50MG/ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Belgium Sandoz N.V. Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE

POWDER FOR SOLUTION FOR

INTRAVENOUS USE

Page 6: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

6

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

1000MG VIAL INJECTION Belgium Sandoz N.V. Vancomycine Sandoz VANCOMYCIN

HYDROCHLORIDE 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Belgium Teva Pharma Belgium N.V.-S.A

Vancomycine Teva VANCOMYCIN HYDROCHLORIDE 1G

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Belgium Teva Pharma Belgium N.V.-S.A

Vancomycine Teva VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Belgium Mylan Bvba-Sprl Vancomylan VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Belgium Mylan Bvba-Sprl Vancomylan VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

DIRECT INTRAVENOUS INJECTION

Belgium Mylan Bvba-Sprl Vancomylan VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Bulgaria Lek Pharmaceuticals D.D. Ljubljana

Edicin VANCOMYCIN HYDROCHLORIDE 1G VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Bulgaria Tchaikapharma High Quality Medicines, Inc.

Vancocin Cp VANCOMYCIN HYDROCHLORIDE 1G AMPOULE

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Page 7: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

7

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Bulgaria Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Bulgaria Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Bulgaria Sandoz Pharmaceuticals D.D.

Vancomycin Sandoz VANCOMYCIN HYDROCHLORIDE 1000MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INHALATION USE

Bulgaria Actavis Group Ptc Ehf.

аквисцин VANCOMYCIN HYDROCHLORIDE 1000000 I.U. VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Bulgaria Actavis Group Ptc Ehf.

аквисцин VANCOMYCIN HYDROCHLORIDE 500000 I.U. VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Bulgaria Mip Pharma Gmbh ванкомицин Mip VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Bulgaria Mip Pharma Gmbh ванкомицин Mip VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Bulgaria Fresenius Kabi Bulgaria Eood

ванкомицин каби VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Bulgaria Fresenius Kabi ванкомицин каби VANCOMYCIN 500MG POWDER FOR INTRAVENOUS USE

Page 8: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

8

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Bulgaria Eood CONCENTRATE FOR SOLUTION FOR INFUSION

Bulgaria Fresenius Kabi Bulgaria Eood

ванкомицин каби VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Bulgaria Hospira Uk Ltd ванкомицин хоспира VANCOMYCIN 50MG/ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Bulgaria Hospira Uk Ltd ванкомицин хоспира VANCOMYCIN 50MG/ML

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Croatia Pliva Hrvatska D.O.O.

Adimicin VANCOMYCIN HYDROCHLORIDE 1000MG/1000 MG

POWDER FOR INJECTION

INTRAVENOUS USE

Croatia Pliva Hrvatska D.O.O.

Adimicin VANCOMYCIN HYDROCHLORIDE 500MG/500 MG

POWDER FOR INJECTION

INTRAVENOUS USE

Croatia Sandoz D.O.O. Edicin VANCOMYCIN HYDROCHLORIDE 0.5G VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Croatia Sandoz D.O.O. Edicin VANCOMYCIN HYDROCHLORIDE 1G VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Croatia Hospira Uk Ltd Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE

POWDER FOR CONCENTRATE FOR

INTRAVENOUS USE, ORAL USE

Page 9: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

9

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

50MG/ML SOLUTION FOR INFUSION

Croatia Fresenius Kabi D.O.O.

Vancomycin Kabi VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Croatia Fresenius Kabi D.O.O.

Vancomycin Kabi VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Croatia Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Croatia Cnp Pharma Gmbh Vankomicin Cnp VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Croatia Pharmaswiss D.O.O. Vankomicin Pharmaswiss

VANCOMYCIN HYDROCHLORIDE 1025.14MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Croatia Pharmaswiss D.O.O. Vankomicin Pharmaswiss

VANCOMYCIN HYDROCHLORIDE 512.57MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Cyprus Sapiens Pharmaceuticals Ltd

Vanco VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Cyprus Pharmaceutical Trading Co Ltd

Vancomycin Hydrochloride Pharmaceutical

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR

INTRAVENOUS USE, ORAL USE

Page 10: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

10

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Trading INFUSION Cyprus Mylan S.A.S Vancomycin Mylan VANCOMYCIN 1G VIAL POWDER FOR

SOLUTION FOR INFUSION

INTRAVENOUS USE

Cyprus Mylan S.A.S Vancomycin Mylan VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Czech Republic Lek Pharmaceuticals D.D.

Edicin VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Czech Republic Lek Pharmaceuticals D.D.

Edicin VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Czech Republic Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Czech Republic Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Czech Republic Cnp Pharma Gmbh Vancomycin Cnp Pharma

VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Czech Republic Cnp Pharma Gmbh Vancomycin Cnp Pharma

VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Czech Republic Hikma Farmacêutica Vancomycin Hikma VANCOMYCIN POWDER FOR INTRAVENOUS USE

Page 11: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

11

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

(Portugal), S.A. 1000MG VIAL CONCENTRATE FOR SOLUTION FOR INFUSION

Czech Republic Hikma Farmacêutica (Portugal), S.A.

Vancomycin Hikma VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Czech Republic Fresenius Kabi S.R.O Vancomycin Kabi VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Czech Republic Fresenius Kabi S.R.O Vancomycin Kabi VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Czech Republic Mylan S.A.S Vancomycin Mylan VANCOMYCIN HYDROCHLORIDE 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Czech Republic Mylan S.A.S Vancomycin Mylan VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Czech Republic Hospira Uk Ltd Vanmicira VANCOMYCIN 50MG/ML

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Denmark Mip Pharma Gmbh Bactocin VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Page 12: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

12

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Denmark Mip Pharma Gmbh Bactocin VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Denmark Strides Arcolab International Limited

Vancocin VANCOMYCIN HYDROCHLORIDE 125MG CAPSULE

CAPSULE, HARD ORAL USE

Denmark Strides Arcolab International Limited

Vancocin VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE

CAPSULE, HARD ORAL USE

Denmark Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Denmark Cnp Pharma Gmbh Vancomycin "cnp" VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Denmark Farmaplus A.S. Vancomycin "farmaplus"

VANCOMYCIN HYDROCHLORIDE 0.5G BOTTLE

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Denmark Farmaplus A.S. Vancomycin "farmaplus"

VANCOMYCIN HYDROCHLORIDE 1G BOTTLE

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Denmark Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Denmark Actavis Group Ptc Vancomycin Actavis VANCOMYCIN 500MG POWDER FOR INTRAVENOUS USE

Page 13: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

13

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Ehf. VIAL CONCENTRATE FOR SOLUTION FOR INFUSION

Denmark Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 125MG CAPSULE

CAPSULE, HARD ORAL USE

Denmark Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 250MG CAPSULE

CAPSULE, HARD ORAL USE

Denmark Fresenius Kabi Ab Vancomycin Fresenius Kabi

VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Denmark Fresenius Kabi Ab Vancomycin Fresenius Kabi

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Denmark Hospira Enterprise Bv Vancomycin Hospira VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Denmark Hospira Enterprise Bv Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 1G VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Denmark Orion Corporation Vancomycin Orion VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Denmark Orion Corporation Vancomycin Orion VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR

INTRAVENOUS USE

Page 14: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

14

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

INFUSION Denmark Sandoz A-S Vancomycin Sandoz VANCOMYCIN

HYDROCHLORIDE 1000MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Denmark Sandoz A-S Vancomycin Sandoz VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Denmark Teva Denmark A-S Vancomycin Teva VANCOMYCIN HYDROCHLORIDE 1000MG/1000 G

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

CUTANEOUS USE

Denmark Teva Denmark A-S Vancomycin Teva VANCOMYCIN HYDROCHLORIDE 500MG/MG

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

CUTANEOUS USE

Denmark Xellia Pharmaceuticals Aps

Vancomycin Xellia VANCOMYCIN 125MG CAPSULE

CAPSULE, HARD ORAL USE

Denmark Xellia Pharmaceuticals Aps

Vancomycin Xellia VANCOMYCIN 250MG CAPSULE

CAPSULE, HARD ORAL USE

Denmark Xellia Pharmaceuticals Aps

Vancomycin Xellia VANCOMYCIN HYDROCHLORIDE 1026MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Denmark Xellia Pharmaceuticals Aps

Vancomycin Xellia VANCOMYCIN HYDROCHLORIDE 513MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Estonia Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR

INTRAVENOUS USE

Page 15: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

15

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

INFUSION Estonia Actavis Group Ptc

Ehf. Vancomycin Actavis VANCOMYCIN 500MG

VIAL POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Estonia Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Estonia Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Estonia Hospira Uk Ltd Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 50MG/ML

POWDER FOR SOLUTION FOR INFUSION

ORAL USE

Estonia Hospira Uk Ltd Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 50MG/ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Estonia Fresenius Kabi Polska Sp. Z O.O.

Vancomycin Kabi VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Estonia Fresenius Kabi Polska Sp. Z O.O.

Vancomycin Kabi VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Estonia Sandoz Pharmaceuticals D.D.

Vancomycin Sandoz VANCOMYCIN HYDROCHLORIDE 1000MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Page 16: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

16

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Estonia Sandoz Pharmaceuticals D.D.

Vancomycin Sandoz VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Estonia Mip Pharma Gmbh Vancosan VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Estonia Mip Pharma Gmbh Vancosan VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Finland Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Finland Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 125MG CAPSULE

CAPSULE, HARD ORAL USE

Finland Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 250MG CAPSULE

CAPSULE, HARD ORAL USE

Finland Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Finland Cnp Pharma Gmbh Vancomycin Cnp Pharma

VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Finland Cnp Pharma Gmbh Vancomycin Cnp Pharma

VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Finland Hospira Enterprise Bv Vancomycin Hospira VANCOMYCIN POWDER FOR INTRAVENOUS USE

Page 17: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

17

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

HYDROCHLORIDE 1G VIAL

SOLUTION FOR INJECTION

Finland Hospira Enterprise Bv Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Finland Orion Corporation Vancomycin Orion VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Finland Orion Corporation Vancomycin Orion VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Finland Sandoz A-S Vancomycin Sandoz VANCOMYCIN HYDROCHLORIDE 1000MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Finland Sandoz A-S Vancomycin Sandoz VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Finland Xellia Pharmaceuticals Aps

Vancomycin Xellia VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Finland Xellia Pharmaceuticals Aps

Vancomycin Xellia VANCOMYCIN 125MG CAPSULE

CAPSULE, HARD ORAL USE

Finland Xellia Pharmaceuticals Aps

Vancomycin Xellia VANCOMYCIN 250MG CAPSULE

CAPSULE, HARD ORAL USE

Finland Xellia Pharmaceuticals Aps

Vancomycin Xellia VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR

INTRAVENOUS USE

Page 18: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

18

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

INFUSION Finland Mip Pharma Gmbh Vancosan VANCOMYCIN

1000MG VIAL POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Finland Mip Pharma Gmbh Vancosan VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

France Fresenius Kabi France S.A.S.

Vancomycine Kabi VANCOMYCIN HYDROCHLORIDE 1000MG

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

France Fresenius Kabi France S.A.S.

Vancomycine Kabi VANCOMYCIN HYDROCHLORIDE 500MG

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

France Mip Pharma Gmbh Vancomycine Mip VANCOMYCIN HYDROCHLORIDE 1020MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

France Mip Pharma Gmbh Vancomycine Mip VANCOMYCIN HYDROCHLORIDE 510MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

France Mylan S.A.S Vancomycine Mylan VANCOMYCIN HYDROCHLORIDE 1.025G VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

France Mylan S.A.S Vancomycine Mylan VANCOMYCIN HYDROCHLORIDE 128.25MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

France Mylan S.A.S Vancomycine Mylan VANCOMYCIN HYDROCHLORIDE 256.5MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Page 19: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

19

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

France Mylan S.A.S Vancomycine Mylan VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

France Sandoz Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE 1G VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

France Sandoz Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE 1G VIAL

SOLUTION FOR INFUSION

INTRAVENOUS USE

France Sandoz Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE 125.18MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

France Sandoz Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE 256.3MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

France Sandoz Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Germany Ratiopharm Gmbh Vanco VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Germany Ratiopharm Gmbh Vanco VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Germany Cell Pharm Gmbh Vanco-Cell VANCOMYCIN HYDROCHLORIDE 1025MG/1025 MG

POWDER FOR SOLUTION FOR INFUSION / POWDER FOR ORAL SOLUTION

INTRAVENOUS USE, ORAL USE

Page 20: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

20

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Germany Cell Pharm Gmbh Vanco-Cell VANCOMYCIN HYDROCHLORIDE 512.5MG/512.5 MG

POWDER FOR SOLUTION FOR INFUSION / POWDER FOR ORAL SOLUTION

INTRAVENOUS USE, ORAL USE

Germany Riemser Pharma Gmbh

Vancomycin "lederle" 1000

VANCOMYCIN HYDROCHLORIDE 1000MG

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Germany Riemser Pharma Gmbh

Vancomycin "lederle" 500

VANCOMYCIN HYDROCHLORIDE 500MG

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Germany Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN HYDROCHLORIDE 512.6MG VIAL

POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE, ORAL USE

Germany Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Germany Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Germany Hikma Farmacêutica (Portugal), S.A.

Vancomycin Cp VANCOMYCIN HYDROCHLORIDE 1025.2 - 1040.2MG VIAL

POWDER FOR ORAL SOLUTION, SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Germany Hikma Farmacêutica (Portugal), S.A.

Vancomycin Cp VANCOMYCIN HYDROCHLORIDE 512.6 - 520.1MG VIAL

POWDER FOR ORAL SOLUTION, SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Germany Dr. Friedrich Eberth Vancomycin Dr. VANCOMYCIN CAPSULE, HARD ORAL USE

Page 21: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

21

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Arzneimittel Gmbh Eberth HYDROCHLORIDE 125MG CAPSULE

Germany Dr. Friedrich Eberth Arzneimittel Gmbh

Vancomycin Dr. Eberth

VANCOMYCIN 250MG CAPSULE

CAPSULE, HARD ORAL USE

Germany Riemser Pharma Gmbh

Vancomycin Enterocaps 250mg

VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE

CAPSULE, HARD ORAL USE

Germany Hexal Ag Vancomycin Hexal VANCOMYCIN HYDROCHLORIDE 0.5G VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE, ORAL USE

Germany Hexal Ag Vancomycin Hexal VANCOMYCIN HYDROCHLORIDE 1G VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE, ORAL USE

Germany Hospira Deutschland Gmbh

Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 952.38MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Germany Hospira Deutschland Gmbh

Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 476.19MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Germany Fresenius Kabi Deutschland Gmbh

Vancomycin Kabi VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Germany Fresenius Kabi Deutschland Gmbh

Vancomycin Kabi VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Germany Lyomark Pharma Vancomycin Lyomark VANCOMYCIN POWDER FOR INTRAVENOUS USE

Page 22: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

22

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Gmbh HYDROCHLORIDE 1025MG VIAL

SOLUTION FOR INJECTION/INFUSION

Germany Lyomark Pharma Gmbh

Vancomycin Lyomark VANCOMYCIN HYDROCHLORIDE 512.5MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Germany Mip Pharma Gmbh Vancomycin Mip Pharma

VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Germany Mip Pharma Gmbh Vancomycin Mip Pharma

VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Germany Mylan Dura Gmbh Vancomycin Mylan VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

DIRECT INTRAVENOUS INJECTION

Germany Mylan Dura Gmbh Vancomycin Mylan VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

DIRECT INTRAVENOUS INJECTION

Germany Noridem Enterprises Ltd

Vancomycin Noridem VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Germany Noridem Enterprises Ltd

Vancomycin Noridem VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Germany Ratiopharm Gmbh Vancomycin VANCOMYCIN POWDER FOR ORAL INTRAVENOUS USE,

Page 23: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

23

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Ratiopharm HYDROCHLORIDE 512.5MG VIAL

SOLUTION, POWDER FOR SOLUTION FOR INJECTION

ORAL USE

Germany Xellia Pharmaceuticals Aps

Vanco-Ratiopharm VANCOMYCIN HYDROCHLORIDE 1026MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Germany Xellia Pharmaceuticals Aps

Vanco-Ratiopharm VANCOMYCIN HYDROCHLORIDE 513MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Germany Mip Pharma Gmbh Vanco-Saar VANCOMYCIN HYDROCHLORIDE 1020MG VIAL

POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Germany Mip Pharma Gmbh Vanco-Saar VANCOMYCIN HYDROCHLORIDE 510MG VIAL

POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Germany Cnp Pharma Gmbh Vancosan VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Germany Cnp Pharma Gmbh Vancosan VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Germany Mip Pharma Gmbh Vancosan Oral VANCOMYCIN 500MG VIAL

POWDER FOR ORAL SOLUTION

ORAL USE

Greece Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Page 24: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

24

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Greece Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Greece Farmaplus A.S. Vancomycin Farmaplus 1000 Mg

VANCOMYCIN HYDROCHLORIDE 1025.2MG UNITS

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Greece Farmaplus A.S. Vancomycin Farmaplus 500 Mg

VANCOMYCIN HYDROCHLORIDE 512.571MG UNITS

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Greece Generics Pharma Hellas Ltd

Vancomycin Generics VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Greece Generics Pharma Hellas Ltd

Vancomycin Generics VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Greece Hospira Uk Ltd Vancomycin Hydrochloride Hospira

VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Greece Fresenius Kabi Hellas A.E.

Vancomycin Kabi VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Greece Fresenius Kabi Hellas A.E.

Vancomycin Kabi VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Greece Noridem Enterprises Ltd

Vancomycin Noridem VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR

INTRAVENOUS USE

Page 25: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

25

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

SOLUTION FOR INFUSION

Greece Noridem Enterprises Ltd

Vancomycin Noridem VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Greece Norma Hellas S.A. Vancomycin Norma VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Greece Vocate φαρμακευτικη αε

Vancomycin Vocate VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Greece Vocate φαρμακευτικη αε

Vancomycin Vocate VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Greece Finixfarm Ltd Vancomycin φοινιξφαρμ

VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Greece Pharmaserve-Lilly Saci

Voncon VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Greece Demo Abee Vondem VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Greece Demo Abee Vondem VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Greece Vianex S.A. Voxin® 1g/Vial VANCOMYCIN 1G VIAL POWDER FOR INTRAVENOUS USE

Page 26: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

26

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

SOLUTION FOR INFUSION

Greece Vianex S.A. Voxin® 500mg/Vial VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Hungary Actavis Group Ptc Ehf.

Selamat VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Hungary Actavis Group Ptc Ehf.

Selamat VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Hungary Pharmacologic Kft Vancocin VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Hungary Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Hungary Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Hungary Hospira Uk Ltd Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 50MG/ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Hungary Fresenius Kabi Hungary Kft.

Vancomycin Kabi VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR

INTRAVENOUS USE

Page 27: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

27

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

SOLUTION FOR INFUSION

Hungary Fresenius Kabi Hungary Kft.

Vancomycin Kabi VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Hungary Pharmaswiss česká Republika S.R.O.

Vancomycin Pharmaswiss

VANCOMYCIN HYDROCHLORIDE 1025.14MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Hungary Pharmaswiss česká Republika S.R.O.

Vancomycin Pharmaswiss

VANCOMYCIN HYDROCHLORIDE 512.57MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Hungary Teva Gyógyszergyár Zrt

Vancomycin-Human Teva Gyógyszergyár

VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Hungary Teva Gyógyszergyár Zrt

Vancomycin-Human Teva Gyógyszergyár

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Iceland Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Iceland Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN HYDROCHLORIDE 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Page 28: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

28

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Iceland Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 125MG CAPSULE

CAPSULE, HARD ORAL USE

Iceland Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 250MG CAPSULE

CAPSULE, HARD ORAL USE

Iceland Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 500MG VIAL

CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Iceland Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Iceland Fresenius Kabi Ab Vancomycin Fresenius Kabi

VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Iceland Fresenius Kabi Ab Vancomycin Fresenius Kabi

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Iceland Hospira Enterprise Bv Vancomycin Hospira VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Iceland Hospira Enterprise Bv Vancomycin Hospira VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Iceland Xellia Pharmaceuticals Aps

Vancomycin Xellia VANCOMYCIN 125MG CAPSULE

CAPSULE, HARD ORAL USE

Iceland Xellia Vancomycin Xellia VANCOMYCIN 250MG CAPSULE, HARD ORAL USE

Page 29: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

29

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Pharmaceuticals Aps CAPSULE Iceland Xellia

Pharmaceuticals Aps Vancomycin Xellia VANCOMYCIN

1000MG VIAL POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Iceland Xellia Pharmaceuticals Aps

Vancomycin Xellia VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Ireland Flynn Pharma Ltd. Vancocin VANCOMYCIN 50MG/ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Ireland Flynn Pharma Limited Vancocin VANCOMYCIN 50MG/ML

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION, POWDER FOR ORAL SOLUTION

INTRAVENOUS USE, ORAL USE

Ireland Flynn Pharma Limited Vancocin Matrigel VANCOMYCIN 125MG CAPSULE

CAPSULE, HARD ORAL USE

Ireland Flynn Pharma Ltd. Vancocin Matrigel VANCOMYCIN 125MG CAPSULE

CAPSULE, HARD ORAL USE

Ireland Flynn Pharma Limited Vancocin Matrigel VANCOMYCIN 250MG CAPSULE

CAPSULE, HARD ORAL USE

Ireland Flynn Pharma Ltd. Vancocin Matrigel VANCOMYCIN 250MG CAPSULE

CAPSULE, HARD ORAL USE

Ireland Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 1000MG VIAL

CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Ireland Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 500MG VIAL

CONCENTRATE FOR SOLUTION FOR

INTRAVENOUS USE

Page 30: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

30

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

INFUSION Ireland Actavis Group Ptc

Ehf. Vancomycin Actavis Group

VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Ireland Actavis Group Ptc Ehf.

Vancomycin Actavis Group

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Ireland Fresenius Kabi Limited

Vancomycin Fresenius Kabi

VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Ireland Fresenius Kabi Limited

Vancomycin Fresenius Kabi

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Ireland Hikma Farmacêutica (Portugal), S.A.

Vancomycin Hikma Farmacêutica (Portugal), S.A.

VANCOMYCIN 50MG/ML

SOLUTION FOR INFUSION

INTRAVENOUS USE

Ireland Hospira Uk Ltd Vancomycin Hydrochloride Hospira Uk

VANCOMYCIN HYDROCHLORIDE 1G VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Ireland Hospira Uk Ltd Vancomycin Hydrochloride Hospira Uk

VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Page 31: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

31

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Ireland Generics [uk] Limited Vancomycin Mylan VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Ireland Generics [uk] Limited Vancomycin Mylan VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Ireland Mcdermott Laboratories Ltd

Vancomycin Mylan VANCOMYCIN 50MG/ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Ireland Noridem Enterprises Ltd

Vancomycin Noridem Enterprises

VANCOMYCIN 50MG/ML

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Ireland Noridem Enterprises Ltd

Vancomycin Noridem Enterprises Ltd.

VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Ireland Pfizer Healthcare Ireland

Vancomycin Pfizer Healthcare Ireland

VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Ireland Pfizer Healthcare Ireland

Vancomycin Pfizer Healthcare Ireland

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Italy Genetic Spa Levovanox VANCOMYCIN 1G VIAL ORAL SOLUTION, INTRAVENOUS USE,

Page 32: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

32

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

POWDER FOR INFUSION

ORAL USE

Italy Genetic Spa Levovanox VANCOMYCIN 250MG CAPSULE

CAPSULE, HARD ORAL USE

Italy Genetic Spa Levovanox VANCOMYCIN 500MG VIAL

ORAL SOLUTION, POWDER FOR INFUSION

INTRAVENOUS USE, ORAL USE

Italy Genetic Spa Maxivanil VANCOMYCIN HYDROCHLORIDE 1025.14MG VIAL

POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Italy Genetic Spa Maxivanil VANCOMYCIN HYDROCHLORIDE 256MG CAPSULE

CAPSULE, HARD ORAL USE

Italy Genetic Spa Maxivanil VANCOMYCIN HYDROCHLORIDE 512.57MG VIAL

POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Italy Eli Lilly Italia S.P.A. Vancocina A.P. VANCOMYCIN HYDROCHLORIDE 512.57MG VIAL

POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Italy Hikma Italia S.P.A. Vancomicina VANCOMYCIN HYDROCHLORIDE 1025.14MG VIAL

POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Italy Hikma Italia S.P.A. Vancomicina Hikma VANCOMYCIN HYDROCHLORIDE

POWDER FOR ORAL SOLUTION, POWDER

INTRAVENOUS USE, ORAL USE

Page 33: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

33

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

1025.14MG VIAL FOR SOLUTION FOR INFUSION

Italy Hikma Italia S.P.A. Vancomicina Hikma VANCOMYCIN HYDROCHLORIDE 512.57MG BOTTLE

POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Italy Hospira Spa Vancomicina Hospira VANCOMYCIN HYDROCHLORIDE 1.025G VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Italy Hospira Spa Vancomicina Hospira VANCOMYCIN HYDROCHLORIDE 512.5MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Italy Fresenius Kabi Italia S.R.L.

Vancomicina Kabi VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Italy Fresenius Kabi Italia S.R.L.

Vancomicina Kabi VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Italy Mylan S.P.A. Vancomicina Mylan VANCOMYCIN 50MG/ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Italy Farmaplus As Vancomycin Farmaplus

VANCOMYCIN 50MG/ML

SOLUTION FOR INFUSION

INTRAVENOUS USE

Italy Pharmatex Italia Srl Vancotex VANCOMYCIN HYDROCHLORIDE 512.57MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Page 34: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

34

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Italy Pharmatex Italia Srl Vancotex VANCOMYCIN HYDROCHLORIDE 1025.14MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Italy Fisiopharma Srl Zengac VANCOMYCIN HYDROCHLORIDE 1025.14MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Italy Fisiopharma Srl Zengac VANCOMYCIN HYDROCHLORIDE 512.57MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Latvia Lek Pharmaceuticals D.D. Ljubljana

Edicin VANCOMYCIN HYDROCHLORIDE 1000000 I.U. G

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Latvia Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Latvia Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Latvia Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Latvia Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Latvia Hospira Uk Ltd Vancomycin Hospira VANCOMYCIN 50MG/ML

POWDER FOR CONCENTRATE FOR

INTRAVENOUS USE, ORAL USE

Page 35: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

35

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

SOLUTION FOR INFUSION

Latvia Fresenius Kabi Polska Sp. Z O.O.

Vancomycin Kabi VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Latvia Fresenius Kabi Polska Sp. Z O.O.

Vancomycin Kabi VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Latvia Pfizer Europe Ma Eeig Vancomycin Pfizer VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Latvia Pfizer Europe Ma Eeig Vancomycin Pfizer VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Latvia Sandoz Pharmaceuticals D.D.

Vancomycin Sandoz VANCOMYCIN HYDROCHLORIDE 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Latvia Sandoz Pharmaceuticals D.D.

Vancomycin Sandoz VANCOMYCIN HYDROCHLORIDE 1000MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Latvia Mip Pharma Gmbh Vancosan VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Latvia Mip Pharma Gmbh Vancosan VANCOMYCIN 500MG POWDER FOR INTRAVENOUS USE

Page 36: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

36

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

VIAL SOLUTION FOR INFUSION

Lithuania Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Lithuania Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Lithuania Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Lithuania Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Lithuania Hospira Uk Ltd Vancomycin Hospira VANCOMYCIN 50MG/ML

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Lithuania Fresenius Kabi Polska Sp. Z O.O.

Vancomycin Kabi VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Lithuania Fresenius Kabi Polska Sp. Z O.O.

Vancomycin Kabi VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Page 37: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

37

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Lithuania Teva Pharma B.V. Vancomycin Teva VANCOMYCIN 1000 I.U. / MG

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Lithuania Mip Pharma Gmbh Vancosan VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Lithuania Mip Pharma Gmbh Vancosan VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Luxembourg Teva Pharma Belgium N.V.-S.A

Vamysin VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Luxembourg Teva Pharma Belgium N.V.-S.A

Vamysin VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Luxembourg Fresenius Kabi Deutschland Gmbh

Vancomycin Kabi VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Luxembourg Fresenius Kabi Deutschland Gmbh

Vancomycin Kabi VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Luxembourg Sandoz N.V. Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE 1000MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Page 38: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

38

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Luxembourg Sandoz N.V. Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Luxembourg Teva Pharma Belgium N.V.-S.A

Vancomycine Teva VANCOMYCIN 1000MG/20 ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Luxembourg Teva Pharma Belgium N.V.-S.A

Vancomycine Teva VANCOMYCIN 500MG/10 ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Malta Hospira Uk Ltd Vancomycin Hydrochloride Hospira Uk

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Malta Norma Hellas S.A. Vancomycin Norma VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Malta Wockhardt Uk Ltd Vancomycin Wockhardt Uk Ltd

VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Netherlands Eurocept B.V. Vancocin Cp VANCOMYCIN 500MG and 1000MG

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Netherlands Eurocept B.V. Vancocin Cp VANCOMYCIN 250MG CAPSULE

CAPSULE ORAL USE

Netherlands Hospira Benelux Bvba

Vancomycin Hospira VANCOMYCIN 1000MG and 500 MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Netherlands Cnp Pharma Gmbh Vancomycine Cnp VANCOMYCIN POWDER FOR INTRAVENOUS USE

Page 39: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

39

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

1000MG VIAL SOLUTION FOR INFUSION

Netherlands Cnp Pharma Gmbh Vancomycine Cnp VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Netherlands Fresenius Kabi Nederland B.V.

Vancomycine Fresenius Kabi

VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Netherlands Fresenius Kabi Nederland B.V.

Vancomycine Fresenius Kabi

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Netherlands Hikma Farmacêutica (Portugal), S.A.

Vancomycine Hikma VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Netherlands Hikma Farmacêutica (Portugal), S.A.

Vancomycine Hikma VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Netherlands Mylan B.V. Vancomycine Mylan VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Netherlands Mylan B.V. Vancomycine Mylan VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Netherlands Pfizer B.V. Vancomycine Pfizer VANCOMYCIN POWDER FOR INTRAVENOUS USE

Page 40: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

40

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

1000MG VIAL CONCENTRATE FOR SOLUTION FOR INFUSION

Netherlands Pfizer B.V. Vancomycine Pfizer VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Netherlands Pharma Regulatory Solutions Ltd.

Vancomycine Pharma Regulatory

VANCOMYCIN 500 mg per vial

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Netherlands Pharma Regulatory Solutions Ltd.

Vancomycine Pharma Regulatory

VANCOMYCIN 1000 mg per vial

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Netherlands Sandoz B.V. Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE 1000MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Netherlands Sandoz B.V. Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Netherlands Teva Nederland B.V. Vancomycine Teva VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Netherlands Teva Nederland B.V. Vancomycine Teva VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR

INTRAVENOUS USE

Page 41: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

41

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

INFUSION Netherlands Xellia

Pharmaceuticals Aps Vancomycine Xellia VANCOMYCIN

HYDROCHLORIDE 1026MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Netherlands Xellia Pharmaceuticals Aps

Vancomycine Xellia VANCOMYCIN HYDROCHLORIDE 513MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Norway Actavis Group Ptc Ehf.

Vancomycin Actavis Group Ptc Ehf.

VANCOMYCIN 1000MG VIAL

SOLUTION FOR INFUSION

INTRAVENOUS USE

Norway Actavis Group Ptc Ehf.

Vancomycin Actavis Group Ptc Ehf.

VANCOMYCIN 500MG VIAL

SOLUTION FOR INFUSION

INTRAVENOUS USE

Norway Cnp Pharma Gmbh Vancomycin Cnp Pharma

VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Norway Cnp Pharma Gmbh Vancomycin Cnp Pharma

VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Norway Fresenius Kabi Norge As

Vancomycin Fresenius Kabi

VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Norway Fresenius Kabi Norge As

Vancomycin Fresenius Kabi

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Norway Hospira Enterprise Bv Vancomycin Hospira VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Page 42: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

42

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Norway Hospira Enterprise Bv Vancomycin Hospira VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Norway Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Norway Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Norway Farmaplus A.S. Vancomycin Mylan VANCOMYCIN HYDROCHLORIDE 1G BOTTLE

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Norway Farmaplus A.S. Vancomycin Mylan VANCOMYCIN HYDROCHLORIDE 0.5G BOTTLE

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Norway Pfizer As Vancomycin Pfizer VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Norway Pfizer As Vancomycin Pfizer VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Norway Xellia Pharmaceuticals Aps

Vancomycin Xellia VANCOMYCIN 125MG CAPSULE

CAPSULE, HARD ORAL USE

Norway Xellia Vancomycin Xellia VANCOMYCIN POWDER FOR INTRAVENOUS USE

Page 43: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

43

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Pharmaceuticals Aps HYDROCHLORIDE 500MG VIAL

SOLUTION FOR INFUSION

Poland Sandoz Gmbh Edicin VANCOMYCIN HYDROCHLORIDE 1G VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Poland Sandoz Gmbh Edicin VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Poland Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Poland Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Poland Fresenius Kabi Polska Sp. Z O.O.

Vancomycin Kabi VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Poland Fresenius Kabi Polska Sp. Z O.O.

Vancomycin Kabi VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Poland Mip Pharma Polska Sp. Z O.O.

Vancomycin Mip VANCOMYCIN HYDROCHLORIDE 1020MG VIAL

POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Page 44: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

44

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Poland Mip Pharma Polska Sp. Z O.O.

Vancomycin Mip VANCOMYCIN HYDROCHLORIDE 510MG VIAL

POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Poland Sandoz Gmbh Vancomycin Sandoz VANCOMYCIN HYDROCHLORIDE 1000MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Poland Sandoz Gmbh Vancomycin Sandoz VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Portugal Axellia Pharmaceuticals ApS

Vancomicina Axelia Vancomycin hydrochloride 1000 vial

POWDER FOR SOLUTION FOR Injection

intravenous use

Portugal Axellia Pharmaceuticals ApS

Vancomicina Axelia Vancomycin hydrochloride 500 vial

POWDER FOR SOLUTION FOR INjection

intravenous use

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.

Vancomicina Azevedos

VANCOMYCIN Hydrochloride1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A.

Vancomicina Azevedos

VANCOMYCIN Hydrochloride 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Portugal Accord Healthcare Limited

Vancomicina Combino

VANCOMYCIN HYDROCHLORIDE 1000 mg bottle

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Portugal Accord Healthcare Limited

Vancomicina Combino

VANCOMYCIN Hydrochloride 500MG bottle

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Page 45: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

45

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Portugal Generis Farmacêutica, S.A.

Vancomicina Generis VANCOMYCIN HYDROCHLORIDE 1000 mg

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Portugal Generis Farmacêutica, S.A.

Vancomicina Generis VANCOMYCIN HYDROCHLORIDE 500 mg VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Portugal Hikma Farmacêutica (Portugal), S.A.

Vancomicina Hikma VANCOMYCIN Hydrochloride 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Portugal Hikma Farmacêutica (Portugal), S.A.

Vancomicina Hikma VANCOMYCIN HYDROCHLORIDE 1000 mg VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Portugal Hikma Farmacêutica (Portugal), S.A.

Vancomicina Hikma VANCOMYCIN Hydrochloride 500 mg vial

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Portugal Hikma Farmacêutica (Portugal), S.A.

Vancomicina Hikma VANCOMYCIN HYDROCHLORIDE 500 mg vial

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Portugal Fresenius Kabi Pharma Portugal Lda.

Vancomicina Kabi VANCOMYCIN Hydrochloride 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Portugal Fresenius Kabi Pharma Portugal Lda.

Vancomicina Kabi VANCOMYCIN Hydrochloride 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Page 46: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

46

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Portugal Labesfal Laboratorios Almiro, S.A.

Vancomicina Labesfal VANCOMYCIN Hydrochloride1000MG vial

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Portugal Labesfal Laboratorios Almiro, S.A.

Vancomicina Labesfal VANCOMYCIN Hydrochloride 500MG vial

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Portugal Laboratórios Normon, S.A.

Vancomicina Normon VANCOMYCIN HYDROCHLORIDE 1026MG Vial

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, oral use

Portugal Laboratórios Normon, S.A.

Vancomicina Normon VANCOMYCIN HYDROCHLORIDE 513MG Vial

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, oral use

Portugal Quimedical Produtos Farmacêuticos, Lda

Vancomicina Quimedical

VANCOMYCIN HYDROCHLORIDE 1025MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Portugal Quimedical Produtos Farmacêuticos, Lda

Vancomicina Quimedical

VANCOMYCIN HYDROCHLORIDE 512MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Portugal Hospira Portugal Lda Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 1000MG vial

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Portugal Hospira Portugal Lda Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 500MG Vial

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

portugal Anfarm Hellas, S.A Vangrotin Vancomycin hydrochloride 500 Vial

powder for solution for infusion

intravenous use

Page 47: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

47

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Romania Lek Pharmaceuticals D.D. Ljubljana

Edicin VANCOMYCIN HYDROCHLORIDE 1MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Romania Lek Pharmaceuticals D.D. Ljubljana

Edicin VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Romania Mylan S.A.S Vancomicina Farmaplus

VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

DIRECT INTRAVENOUS INJECTION

Romania Mylan S.A.S Vancomicina Farmaplus

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

DIRECT INTRAVENOUS INJECTION

Romania Hospira Uk Ltd Vancomicină Hospira VANCOMYCIN 50MG/ML

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Romania Fresenius Kabi Romania S.R.L.

Vancomicina Kabi VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Romania Fresenius Kabi Romania S.R.L.

Vancomicina Kabi VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Romania Pharmaswiss česká Republika S.R.O.

Vancomicină Pharmaswiss

VANCOMYCIN HYDROCHLORIDE

POWDER FOR SOLUTION FOR

INTRAVENOUS USE, ORAL USE

Page 48: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

48

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

1025.14MG/20 ML INFUSION Romania Pharmaswiss česká

Republika S.R.O. Vancomicină Pharmaswiss

VANCOMYCIN HYDROCHLORIDE 512.57MG/10 ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Romania Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Romania Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Romania Hospira Uk Ltd Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 50MG/ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Slovakia Sandoz Pharmaceuticals D.D.

Edicin VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Slovakia Sandoz Pharmaceuticals D.D.

Edicin VANCOMYCIN HYDROCHLORIDE 1000MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Slovakia Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Slovakia Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Slovakia Mylan S.A.S. Vancomycin FarmaPlus

VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Page 49: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

49

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Slovakia Hospira Uk Ltd Vancomycin Hospira VANCOMYCIN 50MG/ML

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Slovakia Fresenius Kabi S.R.O Vancomycin Kabi VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Slovakia Fresenius Kabi S.R.O Vancomycin Kabi VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Slovakia Mylan S.A.S Vancomycin Mylan VANCOMYCIN 50MG/ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Slovakia Hikma Farmacêutica (Portugal), S.A.

Vancomycin Pharmaswiss

VANCOMYCIN 50MG/ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Slovenia Lek Pharmaceuticals D.D. Ljubljana

Edicin VANCOMYCIN 1MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Slovenia Lek Pharmaceuticals D.D. Ljubljana

Edicin VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Slovenia Mylan S.A.S Vancomycin Mylan VANCOMYCIN 50MG/ML

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Slovenia Actavis Group Ptc Vankomicin Actavis VANCOMYCIN POWDER FOR INTRAVENOUS USE

Page 50: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

50

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Ehf. 1000MG VIAL CONCENTRATE FOR SOLUTION FOR INFUSION

Slovenia Actavis Group Ptc Ehf.

Vankomicin Actavis VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Slovenia FarmaPlus AS Vankomicin FarmaPlus

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Slovenia FarmaPlus AS Vankomicin FarmaPlus

VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Slovenia Fresenius Kabi Deutschland Gmbh

Vankomicin Kabi VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Slovenia Fresenius Kabi Deutschland Gmbh

Vankomicin Kabi VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Slovenia Lek Pharmaceuticals D.D. Ljubljana

Vankomicin Lek VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Slovenia Lek Pharmaceuticals D.D. Ljubljana

Vankomicin Lek VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR

INTRAVENOUS USE

Page 51: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

51

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

INJECTION Slovenia Pfizer Luxembourg

Sarl Vankomicin Pfizer VANCOMYCIN

1000MG VIAL POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Slovenia Pfizer Luxembourg Sarl

Vankomicin Pfizer VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Spain Cnp Pharma Gmbh Vancomicina CNP VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Spain Cnp Pharma Gmbh Vancomicina CNP VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Spain Hospira Productos Farmacéuticos Y Hospitalarios, S.L.

Vancomicina Hospira VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE, ORAL USE

Spain Hospira Productos Farmacéuticos Y Hospitalarios, S.L.

Vancomicina Hospira VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE, ORAL USE

Spain Accord Healthcare S.L.U.

Vancomicina IV Accord

VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Spain Accord Healthcare S.L.U.

Vancomicina IV Accord

VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Spain Fresenius Kabi Vancomicina Kabi VANCOMYCIN POWDER FOR INTRAVENOUS USE

Page 52: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

52

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

España S.A.U. 1000MG VIAL CONCENTRATE FOR SOLUTION FOR INFUSION

Spain Fresenius Kabi España S.A.U.

Vancomicina Kabi VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Spain Kern Pharma, S.L. Vancomicina Kern Pharma

VANCOMYCIN HYDROCHLORIDE 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Spain Kern Pharma, S.L. Vancomicina Kern Pharma

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Spain Mylan Pharmaceuticals, S.L.

Vancomicina Mylan VANCOMYCIN 50MG/ML

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Spain Laboratorios Normon, S.A.

Vancomicina Normon VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Spain Laboratorios Normon, S.A.

Vancomicina Normon VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Spain Pfizer, S.L. Vancomicina Pfizer VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR

INTRAVENOUS USE

Page 53: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

53

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

INFUSION Spain Pfizer, S.L. Vancomicina Pfizer VANCOMYCIN 500MG

VIAL POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Spain Laboratorio Ramon Sala, S.L

Vancomicina Sala VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Spain Laboratorio Ramon Sala, S.L

Vancomicina Sala VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Sweden Pharmacodane Aps Vancocin VANCOMYCIN 125MG CAPSULE

CAPSULE, HARD ORAL USE

Sweden Farmaplus A.S. Vancomycin VANCOMYCIN HYDROCHLORIDE 1G BOTTLE

POWDER FOR INFUSION

INTRAVENOUS USE

Sweden Farmaplus A.S. Vancomycin VANCOMYCIN HYDROCHLORIDE 500MG BOTTLE

POWDER FOR INFUSION

INTRAVENOUS USE

Sweden Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Sweden Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 125MG CAPSULE

CAPSULE, HARD ORAL USE

Sweden Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 250MG CAPSULE

CAPSULE, HARD ORAL USE

Sweden Actavis Group Ptc Vancomycin Actavis VANCOMYCIN 500MG POWDER FOR INTRAVENOUS USE

Page 54: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

54

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Ehf. VIAL CONCENTRATE FOR SOLUTION FOR INFUSION

Sweden Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Sweden Cnp Pharma Gmbh Vancomycin Cnp VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Sweden Farmaplus As Vancomycin Farmaplus

VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Sweden Hospira Enterprise Bv Vancomycin Hospira VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Sweden Hospira Enterprise Bv Vancomycin Hospira VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Sweden Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Sweden Mip Pharma Gmbh Vancomycin Mip VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Sweden Mylan Hospital As Vancomycin Mylan VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Page 55: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

55

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

Sweden Mylan Hospital As Vancomycin Mylan VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Sweden Orion Corporation Vancomycin Orion VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Sweden Orion Corporation Vancomycin Orion VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Sweden Sandoz A-S Vancomycin Sandoz VANCOMYCIN HYDROCHLORIDE 1000MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Sweden Sandoz A-S Vancomycin Sandoz VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

Sweden Xellia Pharmaceuticals Aps

Vancomycin Xellia VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Sweden Xellia Pharmaceuticals Aps

Vancomycin Xellia VANCOMYCIN 125MG CAPSULE

CAPSULE, HARD ORAL USE

Sweden Xellia Pharmaceuticals Aps

Vancomycin Xellia VANCOMYCIN 250MG CAPSULE

CAPSULE, HARD ORAL USE

Sweden Xellia Pharmaceuticals Aps

Vancomycin Xellia VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

Page 56: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

56

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

United Kingdom Flynn Pharma Ltd. Vancocin VANCOMYCIN 1G VIAL POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

United Kingdom Flynn Pharma Ltd. Vancocin VANCOMYCIN 500MG VIAL

POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

United Kingdom Flynn Pharma Limited Vancocin Matrigel VANCOMYCIN 125MG CAPSULE

CAPSULE, HARD ORAL USE

United Kingdom Flynn Pharma Ltd. Vancocin Matrigel VANCOMYCIN 125MG CAPSULE

CAPSULE, HARD ORAL USE

United Kingdom Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

United Kingdom Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

United Kingdom Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 125MG CAPSULE

CAPSULE, HARD ORAL USE

United Kingdom Actavis Group Ptc Ehf.

Vancomycin Actavis VANCOMYCIN 250MG CAPSULE

CAPSULE, HARD ORAL USE

United Kingdom Co-Pharma Limited Vancomycin Co-Pharma

VANCOMYCIN 125MG CAPSULE

CAPSULE, HARD ORAL USE

United Kingdom Co-Pharma Limited Vancomycin Co-Pharma

VANCOMYCIN 250MG CAPSULE

CAPSULE, HARD ORAL USE

Page 57: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

57

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

United Kingdom Fresenius Kabi Limited

Vancomycin Fresenius Kabi

VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

United Kingdom Fresenius Kabi Limited

Vancomycin Fresenius Kabi

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

United Kingdom Hikma Farmacêutica (Portugal), S.A.

Vancomycin Hikma Farmacêutica (Portugal), S.A.

VANCOMYCIN HYDROCHLORIDE 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

United Kingdom Hikma Farmacêutica (Portugal), S.A.

Vancomycin Hikma Farmacêutica (Portugal), S.A.

VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

United Kingdom Hospira Uk Ltd Vancomycin Hydrochloride Hospira Uk

VANCOMYCIN 1G VIAL POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

United Kingdom Hospira Uk Ltd Vancomycin Hydrochloride Hospira Uk

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

United Kingdom Laboratorio Reig Jofre, S.A.

Vancomycin Laboratorio Reig Jofré

VANCOMYCIN 1G VIAL POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

Page 58: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

58

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

United Kingdom Laboratorio Reig Jofre, S.A.

Vancomycin Laboratorio Reig Jofré

VANCOMYCIN 500MG VIAL

POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

United Kingdom Mip Pharma Gmbh Vancomycin Mip Pharma Gmbh

VANCOMYCIN 1000MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

United Kingdom Mip Pharma Gmbh Vancomycin Mip Pharma Gmbh

VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

United Kingdom Morningside Healthcare Ltd

Vancomycin Morningside Healthcare

VANCOMYCIN HYDROCHLORIDE 128.15MG CAPSULE

CAPSULE, HARD ORAL USE

United Kingdom Noridem Enterprises Ltd

Vancomycin Noridem Enterprises

VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

United Kingdom Noridem Enterprises Ltd

Vancomycin Noridem Enterprises

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

United Kingdom Nrim Limited Vancomycin Nrim VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

United Kingdom Nrim Limited Vancomycin Nrim VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR

INTRAVENOUS USE

Page 59: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

59

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

INFUSION United Kingdom Pfizer Limited Vancomycin Pfizer VANCOMYCIN

1000MG VIAL POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

United Kingdom Pfizer Limited Vancomycin Pfizer VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

United Kingdom Sandoz Ltd Vancomycin Sandoz Ltd

VANCOMYCIN HYDROCHLORIDE 1000MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

United Kingdom Sandoz Ltd Vancomycin Sandoz Ltd

VANCOMYCIN HYDROCHLORIDE 500MG VIAL

POWDER FOR SOLUTION FOR INJECTION

INTRAVENOUS USE

United Kingdom Teva Uk Limited Vancomycin Teva Uk VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

United Kingdom Teva Uk Limited Vancomycin Teva Uk VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

United Kingdom Wockhardt Uk Ltd Vancomycin Wockhardt Uk Ltd

VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR INFUSION

INTRAVENOUS USE, ORAL USE

United Kingdom Wockhardt Uk Ltd Vancomycin Wockhardt Uk Ltd

VANCOMYCIN 500MG VIAL

POWDER FOR SOLUTION FOR

INTRAVENOUS USE, ORAL USE

Page 60: Vancomycin Article 31-1440€¦ · VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE CAPSULE, HARD . ORAL USE : Austria . Hikma Farmacêutica (Portugal), S.A. Vancomycin Hikma . VANCOMYCIN 1000MG

60

Member State

EU/EEA

Marketing authorisation holder

Invented name INN + Strength Pharmaceutical form

Route of administration

INFUSION United Kingdom Xellia

Pharmaceuticals Aps Vancomycin Xellia Pharmaceuticals

VANCOMYCIN 250MG CAPSULE

CAPSULE ORAL USE

United Kingdom Xellia Pharmaceuticals Aps

Vancomycin Xellia Pharmaceuticals Aps

VANCOMYCIN 125MG CAPSULE

CAPSULE ORAL USE

United Kingdom Xellia Pharmaceuticals Aps

Vancomycin Xellia Pharmaceuticals Aps

VANCOMYCIN 1000MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE

United Kingdom Xellia Pharmaceuticals Aps

Vancomycin Xellia Pharmaceuticals Aps

VANCOMYCIN 500MG VIAL

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

INTRAVENOUS USE